Aldena Therapeutics Selects PCI Pharma Services to Manufacture & Distribute Innovative Investigational Treatment for Dermatological Diseases

Aldena Therapeutics has chosen PCI Pharma Services (PCI) to formulate, package, and distribute ALD-102, an siRNA-based investigational injectable treatment for inflammatory dermatological conditions, all under one roof at PCI’s San Diego facility. ALD-102 is currently in preclinical trials and represents the most advanced therapy in Aldena’s pipeline.

PCI’s Robotic Gloveless Isolator Vial Filling Technology

Dermatological diseases affect more than 900 million people worldwide. Significant advancements in the treatment of various skin conditions and disorders have been made. However, there are still limitations and challenges in the field. With the siRNA-based approach, Aldena develops advanced and long-lasting treatments for skin conditions. CDMOs are playing a critical role in the large and small- medium pharmaceutical value chain, to bring these life-changing therapies to patients.

“We are very pleased as Aldena’s agreement with PCI has given us the integrated services and support we need to meet our ambitious research and development timelines,” said Thibaud Portal, PhD, CEO of Aldena. “This collaboration with PCI will be essential as we continue building our pipeline of new dermatological products targeting conditions for which there is an unmet medical need.”

PCI specializes in development and manufacturing, clinical trial services, advanced drug delivery and commercial technology services. Aldena chose PCI because of its expertise in complex formulations, and cold chain. PCI’s state-of-the-art robotic sterile fill-finish gloveless isolator platform can be used to fill various sterile medications into vials and syringes for small-to-mid size client needs. The equipment, paired with PCI’s end-to-end services and global network, comprises PCI’s Speed to Study™ offering, which drastically decreases the average turnaround time from proposal signing to the injectable product’s distribution for clinical trial use.

The Microcell Vial Filler and SA25 Aseptic Filling Workcell at PCI’s San Diego facility ensures the delivery of medicines from phase I through phase III, supporting local and global Clinical client needs. These advanced machines expedite the filling process with automation and remove the need for human intervention in a sterile environment, creating compliance advantages over standard equipment.

While there is increased demand for siRNA-based therapies in the pharmaceutical industry, only highly specialized CDMOs like PCI can manage the unique handling requirements of fragile large-molecule formulas to manufacture them safely and efficiently.

“We are proud to be one of only a few CDMOs worldwide able to offer integrated sterile fill-finish capabilities, alongside our clinical packaging facilities, to clients who are developing novel and disruptive approaches to treating disease,” said Salim Haffar, CEO of PCI Pharma Services. “Working with innovative companies like Aldena directly ladders back to our mission to provide clinical and commercial supply chain solutions to ultimately improve patients’ lives.”

To better support its clients throughout the world, PCI has recently invested in expansions in Rockford, IL, and Tredegar, Wales, as well as established new facilities in Bedford, NH, and Boston, MA.

Aldena Therapeutics is a Boston, Lausanne, and London-based biotechnology company focusing on siRNA-based treatments for patients suffering from dermatological diseases. The Company was co- founded by Prof. John Harris (MD, PhD, Professor and Chair of Dermatology at UMass Chan Medical School), Prof. Mark Prausnitz (PhD, Regents’ Professor at Georgia Institute of Technology) and Dr Andrew Tadros (MD, PhD) and is backed by international investment firm, Medicxi. Aldena Therapeutics has been led since its inception by dermatology specialist, CEO, Thibaud Portal, PhD, who previously led the Prescription Medicines business and strategy of Galderma SA after several senior R&D roles and co- founded several dermatology focused start-up companies. Aldena is pursuing multiple innovative programs and is currently initiating the IND-enabling GLP nonclinical program for its lead projects.

PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 5,000 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives. For more information, please visit pci.com.